JENA, Germany — December 30, 2025 — Leads & Copy — InflaRx N.V. (Nasdaq: IFRX) has released data analysis from its Phase 3 study of vilobelimab in pyoderma gangrenosum (PG), a trial terminated earlier this year following an Independent Data Monitoring Committee recommendation due to futility.
The analyses include the primary intent-to-treat analysis and several post-hoc analyses on the 54 patients enrolled when the study was halted.
While the Phase 3 trial was terminated due to futility regarding its prespecified primary endpoint, subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect. InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in collaboration with a partner.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, noted the study was the first randomized placebo-controlled study in pyoderma gangrenosum using complete target ulcer closure on two consecutive visits as a stringent primary clinical endpoint. He stated that the in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG. Depending on the outcome of the anticipated FDA interactions, these results may provide an opportunity to advance development in collaboration with a partner.
The Phase 3 study had recruited 54 patients, with 30 completing six months of treatment. The primary endpoint showed a difference in favor of vilobelimab over placebo of 20.8% versus 16.7% (p=NS). Secondary endpoints, such as complete disease remission, showed improvement in favor of vilobelimab over placebo (20.8% versus 5.6%, p=NS), and those with >50% reduction of target ulcer volume at week 26 (36.4% versus 16.7%, p=NS). Patients reported feeling better as measured by the Dermatology Life Quality Index (DLQI) mean percentage change at the end of treatment visit (-31.1% versus 3.4%). Vilobelimab was well tolerated, with mostly mild to moderate treatment-emergent adverse events (TEAEs).
Post-hoc analyses indicated an overall treatment effect with vilobelimab compared to placebo. An MMRM analysis for percent change in target ulcer volume showed an average effect over all visits in favor of vilobelimab over placebo (-45.4%, p=0.0428, Weeks 2 – 26 overall) when imputing patients with treatment-related discontinuation reasons with a last observation carried forward (LOCF) approach. This analysis yielded a significant treatment difference for every week from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo.
ANCOVAs for mean of percentage changes from baseline in volume and area from Week 12 until Week 26 also favored vilobelimab, including mean of percentage change from baseline in volume (p=0.0111) and area (p=0.0072). These analyses suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes.
Alex G. Ortega Loayza, MD, MCR, CWSP, Professor and Interim Chair, Department of Dermatology, Oregon Health and Science University, expressed encouragement regarding the efficacy signals observed from the Phase 3 post-hoc analyses. He noted the role of targeting C5a/C5aR and hopes these findings will motivate further investigation.
Benjamin Kaffenberger, MD, Associate Professor, Dermatology, The Ohio State University Wexner Medical Center, stated that pyoderma gangrenosum remains a difficult-to-treat rare disease with high unmet medical need. He believes the data for vilobelimab suggest an overall treatment effect and that blocking C5a/C5aR continues to make scientific and clinical sense.
InflaRx anticipates meeting with the FDA to discuss a potential path forward for vilobelimab in PG, including alternative endpoints for future clinical studies. The company will prioritize izicopan (INF904) development and consider future vilobelimab development in PG in collaboration with a partner.
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, blocking the biological activity of C5a and demonstrating high selectivity towards its target. It leaves the formation of the membrane attack complex intact. InflaRx was founded in 2007 and has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA.
Contacts:
InflaRx N.V.
MC Services AG
Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
U.S.: +1-339-832-0752
Source: InflaRx N.V.
